Prior treatments for insomnia are primarily limited to behavioral therapy, including Cognitive Behavioral Therapy for Insomnia (CBT-I) and to pharmacological therapy including over the counter medications. Behavioral therapies are lengthy processes, which depend upon the patient's ability to maintain compliance with specific therapeutic activities. Pharmacological therapies raise concerns over long-term use, physiological side effects, and addictive responses.
In general, insomnia presents in multiple manifestations, including latency of sleep onset and waking after sleep onset. Furthermore, insomnia may present as a primary condition or as a secondary condition to other morbidities, including depression, anxiety and post-traumatic stress disorder.
The current practice for diagnosing sleep disorders includes administering a Polysomnogram (PSG), which measures biophysiological activity during sleep. The PSG employs Electroencephalography (EEG) to measure electrical activity within the brain. The EEG data are used to determine the wakefulness of the patient.
Current practice for diagnosing sleep disorders also includes actigraphy, which uses actimetry sensors composed of accelerometers to measure gross motor activity to determine the wakefulness of the patient.
A type of psychotherapy used in the treatment of trauma known as Eye Movement Desensitization and Reprocessing, EMDR, uses bilateral stimulation in conjunction with other psychotherapy mechanisms to achieve more rapid recovery from traumatic events than is normally achieved without bilateral stimulation. It is believed that the bilateral stimulation produces shifts in regional brain activation and neuromodulation similar to those produced during REM sleep, and that this activation shifts the brain into a memory-processing mode similar to that of REM sleep, which permits the integration of traumatic memories.
There are numerous approaches that have been employed to treat and/or ameliorate the effects of insomnia and the ability to maintain a started sleep. One such approach is common behavioral therapy for treating insomnia including stimulus control, such as not working, reading or watching TV in bed, which attempts to eliminate the association of the bed with negative outcomes such as wakefulness and to create a positive association between the bed and sleep.
Another common behavioral therapy for treating insomnia is relaxation training where activities such as guided imagery and muscle relaxation are used to reduce arousal states, which interfere with sleep.
Another common behavioral therapy for treating insomnia is sleep restriction, which limits the amount of time spent in bed when not asleep, and prohibits sleeping during non-prescribed times, e.g. afternoon napping, in order to improve the continuity of sleep.
Another common behavioral therapy for treating insomnia is Cognitive Behavior Therapy for Insomnia (CBT-I), which combines cognitive behavior therapy with other behavior therapies such as sleep restriction, stimulus control and relaxation training.
Another common behavioral therapy for treating insomnia is sleep hygiene, which teaches patients about practices that improve sleep, such as proper diet, exercise, avoiding stimulants, maintaining a quiet sleep environment and avoiding napping.
Another common behavioral therapy for treating insomnia is biofeedback therapy, which utilizes auditory or visual feedback to control some physiological variable in order to reduce arousal states, which interfere with sleep.
Some patients with insomnia are treated with multicomponent behavioral therapy, which combines two or more of the common behavioral therapies.
A common pharmacological therapy for treating insomnia is use of Benzodiazepine Receptor Agonistic Modulators (BzRAs), which act as a hypnotic to induce and maintain sleep.
Another common pharmacological therapy for treating insomnia is use of Non Benzodiazepine Receptor Agonistic Modulators (Non BzRAs), which act as a hypnotic to induce and maintain sleep.
Another common pharmacological therapy for treating insomnia is use of melatonin receptor agonists, which are used primarily for inducing sleep.
Another common pharmacological therapy for treating insomnia is use of a low dose sedating antidepressant, which may be used with comorbid depression.
Some pharmacological therapies for treating insomnia include combinations of BzRAs or Non BZRAs and antidepressants.
Some patients with insomnia treat themselves with over-the-counter antihistamines.
Some patients with insomnia treat themselves with over-the-counter antihistamine-analgesic combinations.
Some patients with insomnia treat themselves with over-the-counter valerian extracts.
Some patients with insomnia treat themselves with over-the-counter melatonin.
Another experimental treatment for treating insomnia is cranial electrotherapy stimulation, which induces a pulsed electric current through the brain using electrodes attached to the scalp or earlobes.
All of the forgoing approaches have disadvantages, which limit their effectiveness. Pharmacological treatments have complications including addiction, amnesia, hallucinations, depression, confusion, suicide ideation and daytime sleepiness. Behavioral therapy techniques are expensive and time consuming, and patients have difficulty complying with protocols. Cranial electrotherapy stimulation is used during daytime and is not an active therapeutic for inducing or maintaining sleep.
A new treatment is needed that is applied in response to a patient's individual physiology, which will actively assist the patient in achieving and maintaining sleep, and which does not have undesirable side effects.